Clinical Trials Office

Vesicoureteral Reflux Study for Children at Least One Year Old

What is the purpose of this study?

Cincinnati Children’s Hospital Medical Center is conducting a research study to find out what effects (good and bad) an implant device that may help keep urine from flowing back into the kidneys and causing infections has on children with vesicoureteral reflux, or VUR. This study also will confirm the long-term safety and effectiveness of the implant device in treating VUR. The United States Food and Drug Administration (FDA) has approved this implant device for use in children at least one year old with VUR grades II-IV.

Who can participate?

Children at least one year old with VUR grades II-IV may be eligible to participate.

Conditions

  • Gastroenterology, Hepatology and Nutrition
  • Urology

What is involved?

Participants will be involved in the research study for up to five years. The study involves a first visit, followed by implantation of the study device, and then six follow-up visits. All aspects of the study will take place at Cincinnati Children’s Hospital Medical Center.

The implantation of the study device is a surgical procedure that involves an injection where the tubes of the kidneys (called ureters) enter the bladder. This procedure requires general anesthesia to put participants “to sleep.” After the procedure, participants will be able to go home without having to stay the night in the hospital and should be able to resume normal activities the day after the procedure.

The following is a list of other procedures that will take place during the study:

    • Physical exams 
    • Blood draws 
    • Urine tests 
    • X-rays of the bladder (also known as a voiding cystourethrogram, or VCUG), if not performed within six months of the study
    • Ultrasounds of the kidneys and bladder, if not performed within six months of the study 
    • Nuclear scans of the kidney, if necessary based on ultrasound results

A detailed list of tests and procedures will be provided to those interested in knowing more about this study.  

What are the benefits?

Participants may or may not receive any direct medical benefit from participating in this study. The results of this study may provide new information that could benefit participants and others with VUR in the future.

Will I get all the facts about the study?

Parents/guardians who are interested in having their children participate will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with parents/guardians to ensure all questions are answered. Study procedures will not begin until this form is signed and participants have given their signed assent.  

Do participants receive pay, compensation or reimbursement?

Families will receive up to $575 as pay for time, travel and inconvenience while participating in the study. Should participants withdraw from the study before the final study visit, families will be paid for each completed visit as follows: Visit 1 - $75; Visit 2 - $25; Visit 3 - $100; Visits 4, 5, 6, 7, 8 - $75 each. In addition, families travelling more than 50 miles may be repaid for mileage and travel expenses after completing the study.

Who should I contact for more information?

Melissa Reed, BSN, RN
Clinical Research Nurse
(513) 803-0053
Clinical Trials Office, MLC 7004
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Principal Investigator

William R. DeFoor, Jr., MD
Principal Investigator
Division of Pediatric Urology
Cincinnati Children’s Hospital Medical Center